UMIN-CTR Clinical Trial

Public title

Targeting Complete Response in Younger transplant-eligible Multiple myeloma patients with Bortezomib and Lenalidomide treatment after relapse with autologous stem cell transplantation

Acronym

CYMBAL study

Scientific Title

Targeting Complete Response in Younger transplant-eligible Multiple myeloma patients with Bortezomib and Lenalidomide treatment after relapse with autologous stem cell transplantation

Scientific Title:Acronym

CYMBAL study

Region

Japan

Condition

multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The study will be conducted to evaluate the safety and efficacy of re-treatment for transplant-eligible multiple myeloma patients who relapsed after autologus stem cell transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The ratio of achivement of CR or more after VRD therapy

Key secondary outcomes

1) Distribution of all response after treatment
2) The ratio of patients who complete the treatment protocol
3) 2 year progression free survival
4) 2 year overall suvival
5) safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1) VRD therapy (4X21-day cycles)
Bortezomib
1.3mg/m2 i.v. or s.c. day1,8,15
Lenalidomide
25mg/body p.o. day1-14
Dexamethasone
40mg/body p.o. day1,8,15

2-1) Patients less than 50 years of age who have candidates for allogenic hematopoietic cell transplantation (allo-HCT) donor
2-1-1) Patients who keep autologous stem cell
Autologous peripheral blood stem cell transplantation (auto PBSCT) followed by allo-HCT
2-1-2) Patients who don't keep autologous stem cell
Peripheral blood stem cell harvest mobilised by cyclophosphamide
PBSC+; auto PBSCT followed by allo-HCT
PBSC-; additional 0-4 cycles of VRD therapy follwed by lenalidomide (LEN) maintenance

2-2) Patients who don't fit 2-1) criteria
2-2-1) Patients who keep autologous stem cell
Auto PBSCT followed by LEN maintenance
2-2-2) Patients who don't keep autologous stem cell
Peripheral blood stem cell harvest mobilised by cyclophosphamide
PBSC+; auto PBSCT followed by LEN maintenance
PBSC-; additional 4 cycles of VRD therapy follwed by LEN maintenance

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
2) Patients who achieved at least partial response (PR) after auto PBSCT with or without consolidation therapy
3) 1 year has elapsed since auto PBSCT
4) Patients who meet the following re-treatment criteria
4-1) Patient with secretory myeloma resulted in clincal relapse
4-2) Patients with PR with monoclonal protein (M protein) levels of less or equal 0.5g/dL, resulted in either the clinical or significant paraprotein relapse
4-3) Patients relapsing from complete response (CR) or very good partial response (VGPR), resulted in either the clinical relapse or paraprotein relapse with 0.5g/dL or more M protein.
5) Patients with a measurable lesion or
quantifiable M protein
6) Patients who are 20 to 65 years old at the time of enrollment in this study
7) Patients in good general condition (in ECOG Performance Status;0to2)
8) Pathents who have the following physical function 14 days before enrollment (N presents the upper limit of the institutional standard value)
8-1) SpO 2;94% or more (including indirect SpO2 measurement)
8-2) neutrophil count;1000/uL or more and platelet count;50000/uL or more
8-3) unnecessary for hemodialysis
8-4)Total bilirubin ;less ore equal 1.5XN, AST ;less or equal2.5XN and ALT ;less ore equal 2.5XN
9) Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method or male patients who agree to contraception by contraceptive operation or other appropriative method
10) Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Imformed Concent Form and Patient Inmormation

Key exclusion criteria

1) Patients with a past history of allergy to the drug described in the protocol
2) Patients daiagnosed plasma cell neoplasm other than symptomatic multiple myeloma
3) Patients who cannnot be expected to live for more than 3 months
4) Patients who have had a complication of active double cancer* within the past 5 years
*Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment, or lesions corresponding to intramucosal carcinoma (cervical carcinoma presenting in FIGO stage I)
5) HBs antigen, HCV antibody or HIV antibody positive patients
6) Patients with grade 2 or severer peripheral neuropathy or peripherl neurogenic pain (CTCAE v4.0)
7) Patients who have or suspected of having a serious active infection
8) Patients with serious mental disorders
9) Patients with serious pulmonary dysfunction
10) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality (e.g. a shadow of ground-glass opacity) on CT scan regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or radiologist)
11) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment
12) Patients who are complicated by poorly controlled diabetes mellitus
13) Patients who are receiving hemodialysis
14) Patients who have serious liver dysfunction
15)Women who are or may be pregnant or are nursing
16) Other patients who are, in the opinion of the caring investigator, unfit for enrolloment in this study

Target sample size

41

Name of lead principal investigator

1st name
Middle name
Last name	Yoshinobu Kanda

Organization

Saitama Medical Center, Jichi Medical University

Division name

Division of Hematology

Zip code

Address

1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama

TEL

048-647-2111

Email

ycanda-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Kiriko Saito

Organization

Saitama Medical Center, Jichi Medical University

Division name

Division of Hematology

Zip code

Address

1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama

TEL

048-647-2111

Homepage URL

Email

goodluck@y7.dion.ne.jp

Institute

Division of Hematology, Saitama Medical Center, Jichi Medical University

Institute

Department

Personal name

Organization

Div. Hematol, Saitama Medical Center, Jichi Medical Univ.
This research fund is in part supported by the donation from Celgene, Kyowa Hakko Kirin, Takeda Pharma, Shionogi Pharma Co., Ltd., etc.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

04

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

04

Month

03

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

04

Month

13

Day

Last modified on

2014

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015995